Honey-based gel composition

ABSTRACT

A honey based composition is described. The composition includes a mixture of honey, a short chain fatty alcohol and a fatty ester or wax. The composition has applications for use in wound dressings and in one embodiment may be a gel. The composition has a higher than expected storage stability, remaining stable for many weeks when held at elevated temperatures and retains all of the other desirable characteristics including anti-microbial activity.

RELATED APPLICATIONS

This application claims priority from NZ584463 dated 7 Apr. 2010, thecontents of which are incorporated herein by reference.

TECHNICAL FIELD

The present application relates to a gel composition. More specifically,the application relates to a storage stable and natural basedcomposition containing honey that has a gel structure and, onapplication to a wound, forms a skin over the wound.

BACKGROUND ART

Honey used in wound dressings has been extensively discussed and taughtin the art.

One of the difficulties of honey for use in wound dressing applicationsis that honey is a naturally sticky substance that if applied to a woundcan be difficult to apply and runny. Solutions have as been proposed inthe art to overcome this drawback of honey and yet still maintain thehoney efficacy in wound treatment.

One example is the use of alginate gums mixed with the honey to formgels. Another alternative is that described in U.S. PublishedApplication No. 2010/0233283. This composition is useful in that thehoney composition is a gel paste or ointment that can be easily packagedin a tube or other pliable container. The gel can easily be squeezed outof the tube and applied to a wound. The gel described in U.S. PublishedApplication No. 2010/0233283 forms a skin over the wound, keeps itsshape when applied to a wound (i.e. does not melt or run), and is easierto apply than pure honey. Further, the composition still retainssufficient honey to provide the desired honey antibacterial and woundhealing effects. A drawback of the composition as described in U.S.Published Application No. 2010/0233283 is that the composition whenstored in the container over time can separate, particularly attemperatures over 30° C. This is undesirable as separation reducesefficacy and aesthetic characteristics of the gel.

Natural based products may also be desirable in many applications,sometimes for improved efficacy and often to aid in marketing theproducts as being natural based and therefore able to be used in avariety nutraceutical applications. A further drawback of thecomposition described in U.S. Published Application No. 2010/0233283 isthat it uses a non-natural ingredient being an ethoxylated oil or PEG60.

It should be appreciated from the above that it would be useful to havea honey based wound dressing gel that was both shelf stable and utilisednatural based ingredients. It is an object of the present application toaddress the foregoing problems or at least to provide the public with auseful choice.

All references, including any patents or patent applications cited inthis specification are hereby incorporated by reference. No admission ismade that any reference constitutes prior art. The discussion of thereferences states what their authors assert, and the applicants reservethe right to challenge the accuracy and pertinence of the citeddocuments. It will be clearly understood that, although a number ofprior art publications are referred to herein, this reference does notconstitute an admission that any of these documents form part of thecommon general knowledge in the art, in New Zealand or in any othercountry.

It is acknowledged that the tem ‘comprise’ may, under varyingjurisdictions, be attributed with either an exclusive or an inclusivemeaning. For the purpose of this specification, and unless otherwisenoted, the term ‘comprise’ shall have an inclusive meaning—i.e. that itwill be taken to mean an inclusion of not only the listed components itdirectly references, but also other non-specified components orelements. This rationale will also be used when the term ‘comprised’ or‘comprising’ is used in relation to one or more steps in a method orprocess.

Further aspects and advantages of the gel composition described hereinwill become apparent from the ensuing description that is given by wayof example only.

SUMMARY

The application broadly relates to a composition containing honey foruse in wound dressings. The composition has a gel consistency that, onapplication to a wound forms skin over the wound. The composition isshelf stable and uses naturally produced products.

In some embodiments, there is provided a composition for treating apatient wherein the composition comprises:

-   -   a. at least 50% wt honey or a honey derivative;    -   b. 2-15% wt of a naturally derived short chain fatty alcohol        with non-ionic surfactant properties;    -   c. 1 to 50% wt of a naturally derived fatty ester, a wax and        wax-like compounds or mixtures thereof having a set point of        45° C. or less,        wherein the composition has been subjected to a sterlisation        effective dosage of radiation and is storage stable for a time        period of at least 24 hours at 40° C.

In some embodiments, there is provided a gel composition consisting of:

-   -   a. 70-90% wt honey    -   b. 2-15% wt myristyl myristate    -   c. 2-10% wt caprylyl capryl glucoside.

The compositions have been found to have a far higher level of stabilitythan existing art compositions. In some embodiments the applicant hasnoted a stability of over 5 weeks at 40° C. or at least 9 weeks whenstored at 30° C., well beyond that of similar products that becameunstable and separated after only 12 hours. A further advantage is thatthe compositions are naturally derived and do not use syntheticallyderived ingredients.

The compositions have applications as a wound gel stored in a tube andapplied to the wound by dispensing the gel from the tube and thenapplying the gel to the wound surface. The composition acts to blockegress of debris from outside the wound into the wound and, due to theantimicrobial and healing effects of honey, acts to prevent infectionand assist wound healing. Since the honey levels in the composition canbe kept high, the efficacy due the honey is retained. Conversely, theother ingredients used avoid other difficulties associated with usinghoney such as being difficult to apply due to it's stickiness and thefact that body temperature causes the honey to run or flow from thewound.

A further advantage of the above composition is that it may beirradiated using standard conditions with no loss in stability of othercharacteristics including efficacy. The art teaches about thedifficulties of irradiation and how irradiation can reduce the efficacy,stability and physical properties of honey based compositions.Irradiation is however essential and an accepted form of sterilisinghoney based compositions used in wound healing. In the applicant'sexperience, irradiation of the honey based composition described hereindoes not alter the characteristics of the composition includingstability.

DETAILED DESCRIPTION

As noted above, the application broadly relates to a compositioncontaining honey for use in wound dressings. The composition has a gelconsistency that, on application to a wound forms skin over the wound.The composition is shelf stable and uses naturally produced products.

For the purposes of this specification, the term ‘surfactant’ refers toa compound that is a wetting agent that reduces the surface tension of aliquid. Surfactants reduce the interfacial tension between oil and waterby adsorbing at the liquid-liquid interface.

The term ‘gel’ refers to a fluidity that lies between a liquid and solidand may incorporate a degree of viscoelasticity.

The term ‘stable’ refers to the composition remaining in suspension andnot undergoing physical, chemical, microbial growth change, or any lossin antibacterial action when stored for a period of time.

The terms ‘UMF’ and ‘non-peroxide activity’ refer to the activity ofhoney not directly attributable to the antimicrobial effects of honeyconferred from the normal honey pH and osmolarity, for example thatobserved and measured in a naturally derived clover honey.

The term ‘honey or honey derivative’ refers to naturally derived honeyor mixtures of honey but may also include honey analogues or derivativessuch as sugar syrup solutions.

The term ‘honey analogue’ refers to a sugar syrup solution approximatingthat of honey e.g. including glucose, fructose, water and eitherhydrogen peroxide and/or one or more hydrogen peroxide precursors.

The term ‘glucoside’ in this specification may be used interchangeablywith the term ‘glycoside’.

The term ‘sterilisation effective dosage of radiation’ refers to a doseof radiation being at least 1 kGy or Ideally 10 kGy or higher.

The term ‘natural based’ refers to compounds obtained from nature or oneor more synthesised versions of compounds found in nature. Ideally, thecompound or compounds used meet the Natural Products Association (NPA)guidelines i.e. they are derived from renewable sources in nature’ theydo not use petroleum compounds, they meet generally recognised as safeor GRAS standard as set by the USA FDA and they are manufactured basedon NPA approved processes.

In some embodiments, a composition is provided for treating a patientwherein the composition comprises:

-   -   a. at least 50% wt honey or a honey derivative;    -   b. 2-15% wt of a naturally derived short chain fatty alcohol        with non-ionic surfactant properties;    -   c. 1 to 50% wt of a naturally derived fatty ester, a wax and        wax-like compounds or mixtures thereof having a set point of        45° C. or less    -   wherein the composition has been subjected to a sterilisation        effective dosage of radiation and is storage stable for a time        period of at least 24 hours at 40° C.

The composition has an unexpected and improved stability over the art.In some embodiments, the composition is stable for at least 8 days whenstored at 40° C. In some embodiments, the composition is stable for atleast 21 days when stored at 40° C. In some embodiments, the compositionis stable for at least 9 weeks when stored at 30° C. In in someembodiments, the composition is stable for at least 15 weeks at 30° C.The anticipated stability when stored at typical ambient conditions islikely to be at least 3 years based on accelerated trials completed bythe applicant. This degree of stability goes well beyond that observedby the applicants for equivalent compositions containing honey,particularly those that have a gel viscosity. For example, in theapplicant's experience, the closest similar composition becomes unstableand phase separates after only 12 hours when stored at 40° C.

The composition is a gel. Gels are a useful consistency for applicationto wounds as the gel can easily by packaged, dispersed form thepackaging and applied to almost any shaped wound. In some embodiments,the composition may have a viscosity of approximately 50×10³ to 600×10³cPs at 25° C. In some embodiments, the viscosity may be 100×10³ to500×10³ cPs at 25° C. In some embodiments, the viscosity may be 300×10³to 400×10³ cPs at 25° C. In some embodiments, the viscosity may be100×10³ to 300×10³ cPs at 25° C. The variation in viscosity may be dueto specific applications where a more runny composition is preferredwhile other applications may require a more viscous composition. By wayof example, the composition may easily be made with a lower and higherviscosity as well without departing from the scope of the invention. Forexample, another gel product, Solosite™ has a viscosity of 45-90×10³ cPsat 25° C.

As noted above, the composition includes at least one topical carrier orvehicle. A wide variety of carriers or vehicles may be used. In someembodiments the at least one carrier or vehicle may have a melting pointof about 37° C. or greater. Preferred carriers or vehicles understood bythe applicant to be useful may include those selected from the groupconsisting of: a fatty ester, synthetic wax, beeswax, vegetal wax,mineral wax, a spermaceti wax constituent, carnauba wax and jojobaliquid wax. In a specific embodiment, the topical carrier or vehicle ismyristyl myristate.

Myristyl myristate is a natural vegetable derived ester compound withemulsifier and opacifier characteristics. Myristyl myristate is oftenused in skin lotions to improve the feel of the compositions as it hasthe effect of thickening compositions. Myristyl myristate is an ester ofmyristic acid, which occurs naturally in animal or vegetable fats andoils.

In some embodiments, the at least one topical carrier or vehiclecomprises from about 10% to about 30% wt of the composition. Morespecifically, the at least one topical carrier or vehicle comprisesabout 15% wt of the composition.

The Interaction of honey and the other compounds of the composition isunderstood to be very important to achieve the desired characteristics.Honey naturally includes water (up to 18% wt). Therefore, in order tocombine and stabilise a myristyl myristate and honey emulsion, asurfactant/emulsifier is required. Olive oil used in the art is an oiland is not soluble in water. Due to these properties, olive oil willonly mix with melted myristyl myristate, but not the honey. In theabsence of a surfactant, once the mixture is cool, myristyl myristatewill go back to its solid phase, but will not be fully dispersed withinthe honey. Instead, the myristyl myristate and olive oil exist as aseparate phase. As will be appreciated from the above, use of asurfactant and the type of surfactant is of importance.

The applicant has unexpectedly found that naturally derived short chainfatty alcohols with non-ionic surfactant properties provide thenecessary surfactant properties to successfully combine the honey andwax and confer the properties desired. These compounds also tend to bemilder on the skin and have a low toxicity. Unexpectedly, the shortchain fatty alcohols confer a greatly increased level of stability overthe art, well beyond that expected or currently observed. In someembodiments, the carbon chain length of the tail of the fatty alcoholmay be from about 6 carbon atoms to about 10 carbon atoms long. In someembodiments, the carbon chain length tail may be 7 to 9 carbon atomslong. In some embodiments, the carbon chain length tall may be 8 carbonatoms long.

By way of example, non-limiting examples of short chain fatty alcoholsthat may be used may be selected from the group consisting of: caprylylcapryl glucoside, coco glucoside, lauryl glucoside, cetearyl olivate,sorbitan olivate, polyglyceryl-6 caprylate, polyglyceryl-6 laurate,polyglyceryl-10 laurate, polyglyceryl-5 oleate, polyglyceryl-5 dioleate,polyglyceryl-10 diisostearate, polyglyceryl-3 stearate, polyglyceryl-3palmitate, polyglyceryl-3 polyricinoleate, glyceryl oleate, sodiumstearoyl lactylate, glyceryl stearate citrate, and combinations thereof.

In a specific embodiment, the applicant has found that the naturallyderived short chain fatty alcohol may be caprylyl capryl glucoside andderivatives thereof. This particular glucoside has been found by theapplicants to confer the ideal properties to the composition includingachieving the desired viscosity, the conversion from a gel to a skin onthe wound when applied, the reduced stickiness of the composition, stillallowing sufficient honey to be present in the composition to achievethe desired antibacterial function. Also a further advantage is that theglucoside is natural based being plant derived and has non-ionicsurfactant properties. The fact that caprylyl capryl glucoside wassuccessful was unexpected as this type of glucoside is normally used invarious foaming and cleaning compositions rather than wound carecompositions owing to its surfactant and foaming characteristics. Inhoney compositions, the surfactant properties appear to assist butfoaming does not occur as in art compositions such as shampoos. Inaddition, use of glucoside and caprylyl capryl glucoside in particularconferred an improved stability, well beyond that found from other artcompositions and beyond what might have been expected in the art basedon published information about glucoside, particularly in combinationwith honey of which there is no known art to the applicant's knowledge.

In some embodiments the composition contains from about 2% to about 10%wt naturally derived short chain fatty alcohol. More specifically, thecomposition contains from about 2% to about 7% wt naturally derivedshort chain fatty alcohol. In some embodiments, the composition containsabout 4-6% wt naturally derived short chain fatty alcohol. In someembodiments, the composition may contain about 5% wt naturally derivedshort chain fatty alcohol.

In some embodiments, the honey used may have both peroxide andnon-peroxide activity. Non-peroxide activity is often usedinterchangeably with the measurement of ‘unique manuka factor’ or UMFactivity. Honey has inherent physical characteristics such as low pH andosmolarity that deter microbial growth however honeys with non-peroxideactivity are often desired or preferred in medical applications due tothe enhanced anti-microbial effects observed from such honeys includingthose honeys derived from the species Leptospermum and specificallyeither Leplospermum scoparium or manuka honey and/or Leptospermumpolygalifolium or jellybush honey.

In some embodiments, the composition may constitute approximately 70-90%wt honey. As should be appreciated, this is ample honey and ensuresactivity well beyond that of more dilute formulations with less than 50%wt such as those taught in the art.

Also as noted in the definition above, although the term ‘honey’ hasbeen used, a honey derivative or honey analogue may equally be usedwithout departing from the scope of the invention.

The sterilisation effective dose as noted above may be greater than 10kGy. In some embodiments the dose may be greater than 20 kGy. In someembodiments, the dose may be greater than 30 kGy. In some embodiments,the dose may be 32.5 kGy to 60 kGy. The applicant has found thatirradiation of the composition does not appreciably alter the stabilityand physical characteristics of the composition unlike some artcompositions that become unstable and separate post irradiationtreatment. Irradiation is important in many applications such as medicalapplications to ensure that there are no residual microbes that maycause infection of a wound.

The pH of the composition also remains stable during storage. In someembodiments the pH of the composition post manufacture and duringstorage may be between 3.0 and 6.0. The pH may be 3.0 to 5.0. The pH maybe 4.0 to 5.0. The pH remains within the specified range for theduration of storage.

In some embodiments there is provided a gel composition consisting of:

-   -   a. 70-90% wt honey    -   b. 2-15% wt myristyl myristate    -   c. 2-10% wt caprylyl capryl glucoside.

In some embodiments, the composition is irradiated with a sterlisationeffective dose of radiation.

In some embodiments, the composition is a gel with similar viscosity tothat described above.

Further, the above embodiments have the same stability characteristicsas that described above including stability for at least 8 days whenstored at 40° C.

Aspects of the broadly described gel composition described above mayalso apply to more specific embodiments without departing from the scopeof the invention.

As should be appreciated from the above description, the intended use ofthe gel composition described herein is as a wound gel that is ideallyapplied to wounds as a gel. The myristyl myristate or other wax helps toprovide the gel consistency but without a surfactant, the myristylmyristate will not disperse into the emulsion. Instead, if it mixes atall, it will exist in the mixture as hard globules within a matrix ofliquid honey. This will fail the required outcome as, in the wound, oncethe honey melts due to the amount of exudate, the waxes will stick tothe wound bed and will be hard to wash away. The use of a non-Ionicsurfactant being a short chain fatty acid and, in some embodiments beingcaprylyl capryl glucoside, meets the desired criteria well includingconferring longevity during storage.

WORKING EXAMPLES

The gel composition of the present application Is now described withreference to examples illustrating embodiments of the composition.

Example 1

A composition containing honey (manuka honey with a UMF level of 12+)(80% wt), myristyl myristate (15% wt) and caprylyl capryl glyceride (5%wt) was manufactured and added to a tube container. The tube containerwas then irradiated at 25 kGy following standard irradiation protocolsused for medical wound dressings that contain honey.

Baseline control tests were completed and the composition appearedsmooth and free of grittiness having a cream like consistency, a softfine grain and little or no glucose crystals.

The pH of the composition was 3.5-4.5 and an antibacterial activity >10%phenol equivalent or >10 UMF activity over the shelf life.

Example 2

A composition containing honey (Jellybush honey with a UMF level of 12+)(80% wt), myristyl myristate (15% wt) and caprylyl capryl glucoside (5%wt) was manufactured and added to a tube container. The tube containerwas then irradiated at 25 kGy following standard irradiation protocolsused for medical wound dressings that contain honey.

Baseline control tests were completed and the composition appearedsmooth and free of grittiness having a cream like consistency, a softfine grain and little or no glucose crystals.

The pH of the composition was 3.5-4.5 and an antibacterial activity >10%phenol equivalent or >10 UMF activity over the shelf life.

Example 3

Further formulation examples are illustrated in Table 1 below showinghow the composition may be made using different compounds.

TABLE 1 Example Compositions (Excludes Carriers) Composition Honey ShortChain Fatty Acid Fatty Ester, wax or wax like compound Number MH JB ANCCG CG LG CO FE SW BW VW MW SW CW JW 1 80 5 15 2 80 5 15 15 3 80 5 15 450 5 45 5 90 5 5 6 88 2 10 7 85 10 5 8 60 15 10 5 10 9 75 5 5 5 5 5

Legend: MH: Manuka Honey JB: Jellybush Honey AN: Honey Analogue

CCG: caprylyl capryl glucoside,CG: coco glucoside,LG: lauryl glucoside,FE: fatty ester,SW: synthetic wax,BW: beeswax,VW: vegetal wax,MW: mineral wax,SW: a spermaceti wax constituent,CW: carnauba waxJW: Jojoba liquid wax

Example 4

In this example, the composition of Example 1 was stored at freezertemperatures (−18° C.) and at high temperature (40° C.) for 21 days andmeasurements of colour, odour, appearance, texture and phase separationtested at time zero and after 3 weeks. These temperatures were chosen tosimulate either extreme of shipping temperature.

The results found are summarised in Table 2 below.

TABLE 2 Sample Test Results Post Storage Storage Storage TimeAppearance/ Phase Conditions (Weeks) Colour Odour Texture SeparationFreezer 3 Light tan to Honey Smooth No brown odour cream like separationopaque consistency colour 40° C. 3 Light tan to Honey Smooth No brownodour cream like separation opaque consistency colour

Example 5

In this example, the composition of Example 1 was stored at an elevatedtemperature 40° C. for one week and then at 30° C. for a further 5 to 8weeks and measurements of colour, odour, appearance, texture, phaseseparation, pH were tested at time zero, after 6 weeks and after 9weeks. These temperatures were chosen to simulate a shippingtemperature.

The results found are summarised in Table 3 below.

TABLE 3 Accelerated Stability at 40/30° C. Test Results Storage TimeAppearance/ Phase (Weeks) Colour Odour Texture Separation pH 0 Light tanto brown Honey Smooth cream No 4.4 opaque emulsion odour likeconsistency separation 6 Light tan to brown Honey Smooth cream No 4.4opaque emulsion odour like consistency separation 9 Light tan to brownHoney Smooth cream No 4.3 opaque emulsion odour like consistencyseparation

There was no total weight change (0.00%) after 9 weeks storage (totalweight change calculated as percent weight change of container, initialcompared to 9 week test weight).

Example 6

The composition described in Example 1 was tested by wound dressingclinicians and a clinical nurse with experience in the area of wounddressings and in particular honey based wound dressing gels.

Observations were collated.

All observations made were that the composition of Example 1:

-   -   1. Was easy to apply to a wound.    -   2. Was easy to clean from the wound and surrounding area post        application.    -   3. Had a uniform consistency when administered to the patient        post manufacture and storage.    -   4. No pain or adverse effects were noted except in two cases        where a slight stinging was noted by the patient on application        that quickly dissipated. This observation is commensurate or        better than that observed with art formulations.    -   5. The wound to which the composition was applied healed as per        prior art formulations.

The above findings showed that the new formulation not only hasincreased stability but still meets all other functional criteria.

Example 7

In this Example, a trial is presented where the stability at 40° C. of acomposition of Example 1 is compared to a composition modelled on thatdescribed in the art, specifically U.S. Pat. No. 6,482,442 (twoformulations) and U.S. Published Application No. 2010/0233283. Thespecific amounts and compounds used in each composition are shown inTable 4 below.

TABLE 4 Compositions Used in 40° C. Stability Trial Example 1 US '442 US'442 Composition Composition 1 Composition 2 US '931 [wt %] [wt %] [wt%] [wt %] Honey 80 80 80 80 Myristyl 15  5 18 15 Myristate Olive Oil —15  2 — PEG60 — — —  5 Caprylyl  5 — — — capryl glusoside

As should be apparent from Table 4, the key difference between thedifferent compositions was the surfactant/emulsifier used. Allcompositions used the same type and amount of honey while the amount ofmyristyl myristate was varied to either extreme taught as beingacceptable in the US '442 specification.

The Example 1 composition was mixed, irradiated and then stored at 40°C. When the trial ended at Day 8, the Example 1 composition hadidentical characteristics to that at the start of the trial, remainingstable for the 8-day duration.

The composition based on US '283 was mixed together and irradiated inthe same manner as the composition of Example 1. Initial characteristicsof the US '283 composition were the same as that of the Example 1composition at the beginning of the trial. However, within a 12 hourtime period, the US '283 composition separated and hence was unstable atelevated storage temperatures.

Both of the compositions based on US '442 were highly unstable. Neithersample could be mixed together even before irradiation took place. Inthe case of the US '442 Composition 1 mixture, despite vigorous mixingthe oil formed a separate layer on the top of the honey and myristylmyristate. In the case of the US '442 Composition 2 mixture, againdespite vigorous mixing, the myristyl myristate formed a separate layeron the top of the honey and oil.

The above results confirm the need for a surfactant/emulsifier in orderto have the honey and wax such as myristyl myristate combine. Theresults also demonstrate how use of caprylyl capryl glucoside confersconsiderably greater stability than that observed using othersurfactants/emulsifiers such as PEG60.

Example 8

The microbial growth stability of the composition was tested to confirmthat, post storage, microbial growth did not occur. As may beappreciated, particularly for medical applications, microbial growth isof significant concern and must be avoided.

A total of five separate samples were taken based on the compositiondescribed in Example 1. The samples were stored at 40° C. for 8 days.Following storage, the samples were stored aseptically and transportedto a laboratory where they were analysed for microbial growth byreference to tests for:

-   -   (a) Growth on tryptone soya broth at 22.5+/−2.5° C. for 14 days;        and,    -   (b) Growth on thioglycollate medium at 32.5+/−2.5° C. for 14        days.

None of the five samples tested had any microbial growth detected viaeither test illustrating that the composition of the present inventionis stable with respect to microbial growth.

Example 9

A further test was completed to determine the stability of thecomposition for an extended time period.

A composition containing honey (manuka honey with a UMF level of 12+)(80% wt), myristyl myristate (15% wt) and caprylyl capryl glucoside (5%wt) was manufactured and added to a tube container. The tube containerwas then irradiated at 35 kGy following standard irradiation protocolsused for medical wound dressings that contain honey.

The trial comprised of two tests, one being a comparison between samplesstored at −18 C against the same sample stored at 40 C. A second trialstudied the stability of the composition in an accelerated study withhoney stored at 30 C.

Table 5 below shows the results of the first study while Table 6 belowshows the results of the second study.

TABLE 5 High versus Low Temperature Comparison Study Storage time &Appearance & Phase conditions Colour Odour texture Separation 1 wk −18°C. Caramel Sweet Smooth cream No & 3 wks 40° C. brown honey likeconsistency, separation few glucose crystals 2 wk −18° C. Opaque tanHoney Smooth cream No & 3 wks 40° C. colour like consistency separation3 wks −18° C. Light tan to Honey Smooth cream No & 3 wks 40° C. Brownlike consistency separation

TABLE 6 Accelerated stability at 30 C. Storage Activity time Appearance/Phase Packaging (non- (weeks) Colour Odour Texture Separation integritypH peroxide) 0 Light tan to Honey Smooth No Intact. Text 4.4 Error withbrown cream like separation legible testing consistency 3 Light brown/Sharp Smooth No Intact. Text 4.5 11.89 yellow Honey cream likeseparation legible consistency 6 Light tan to Honey Smooth No Intact.Text 4.4 14.25 brown opaque cream like separation legible consistency 9Light brown/ Sharp Smooth No Intact. Text 4.3 16.24 yellow opaque honeycream like separation legible consistency 12 Light brown/ Sharp SmoothNo Intact. Text 4 15.52 yellow opaque honey cream like separationlegible consistency 15 Light brown/ Sharp Smooth No Intact. Text 4 18.39yellow opaque honey cream like separation legible consistency

The above results show that the composition is stable for at least 15weeks when stored at 30 C and illustrates minimal difference betweenfreezer storage versus 400 storage. The results when applied to morenormal ambient conditions support a shelf life of at least 3 years.

Example 10

A test to confirm the efficacy of the composition was completed.Ordinary honey with or without non-peroxide activity is known to have anantibacterial effect. The aim of the trial was to ensure that thecomposition of the invention did not compromise the antibacterialefficacy of key importance in proposed wound dressing applications.

Samples produced as per Example 1 were stored at 40° C. for 48 hours, 7days, 14 days and 28 days and at each stage tested for microbial count.The initial inoculum and a time zero count were also measured. Theresults found are illustrated in Table 7 below.

TABLE 7 Antibacterial Effects for the Composition [CPU = colony formingunits; <=less than] Initial Recovery Counts (CFU/gram) ChallengeInoculum Time 48 7 14 28 Organism (CFU/gram) “0” hrs days days days S.aureus 2.9 × 10⁶ 1.8 × 10⁵ <10 <10 — <10 P. aeruginosa 3.4 × 10⁶ 1.4 ×10⁵ <10 <10 <10 C. albicans 5.6 × 10⁶ 4.7 × 10⁴ — — <10 <10 A. niger 3.6× 10⁶ 4.3 × 10⁵ — — <10 <10

As shown above, the composition in accordance with embodiments describedherein had an immediate and catastrophic effect on microbial growth withmicrobes tested being killed to less than detectable levels within 48hours. This effect is the same as that observed using honey hence it canbe concluded that the composition described herein retains theantibacterial effects of honey.

Example 11

In this example the viscosity of the composition described in Example 1was tested. Three samples of the composition were tested and averaged toestablish a viscosity figure. The method used a Brookfleld Viscometerwith Helipath Spindle F at 1.5 rpm and 25° C.

The test identified that the viscosity was approximately 300-400×10³cPs@25° C.

Example 12

Further viscosity measurements were taken of varying formulations basedon the same method as that described in Example 11 above.

Results found are illustrated below in Table 8.

TABLE 8 Viscosity Measurements Sample Number Viscosity [cPs @°25] 1254000 2 210000 3 454000 4 180000 5 423000 6 168000 7 158000 8 158000 9189200

The variation shown above lustrates how the composition viscosity may bevaried for differing applications.

Aspects of the gel composition described herein have been described byway of example only and it should be appreciated that modifications andadditions may be made thereto without departing from the scope of theclaims herein.

1. A composition for treating a patient wherein the compositioncomprises: a. 70-90 wt % honey; b. 2-10 wt % caprylyl/capryl glucoside;and c. 2-15 wt % myristyl myristate; wherein the composition has beensubjected to a sterilization effective dosage of radiation and isstorage stable for a time period of at least 24 hours at 40° C.
 2. Thecomposition as claimed in claim 1, wherein the composition is stable forat least 8 days when stored at 40° C.
 3. The composition as claimed inclaim 1, wherein the composition is stable for at least 21 days whenstored at 40° C.
 4. The composition as claimed in claim 1, wherein thecomposition is stable for at least 15 weeks when stored at 40° C.
 5. Thecomposition as claimed in claim 1, wherein the composition is a gel. 6.The composition as claimed in claim 1, wherein the composition has aviscosity of 50×10³ to 600×10³ cPs at 25° C.
 7. The composition asclaimed in claim 1, wherein the myristyl myristate has a melting pointof about 37° C. or greater.
 8. The composition as claimed in claim 1,wherein the honey has both peroxide and non-peroxide activity.
 9. Thecomposition as claimed in claim 1, wherein the pH is between 3.0 and 6.0for the duration of storage.
 10. The composition as claimed in claim 1,wherein the pH is between 4.0 and 5.0 for the duration of storage. 11.The composition as claimed in claim 1, wherein the sterilizationeffective dosage of radiation is greater than 10 kGy.
 12. Thecomposition as claimed in claim 1, wherein the sterilization effectivedosage of radiation is greater than 20 kGy.
 13. The composition asclaimed in claim 1, wherein the sterilization effective dosage ofradiation is 25 kGy.
 14. The composition as claimed in claim 1, whereinthe composition has an antibacterial activity >10% phenol equivalentor >10 unique manuka factor activity over the shelf life.
 15. Thecomposition as claimed in claim 1, wherein the honey is manuka honey.16. The composition as claimed in claim 15, wherein the composition isstable for at least 8 days when stored at 40° C.
 17. The composition asclaimed in claim 15, wherein the composition is stable for at least 21days when stored at 40° C.
 18. The composition as claimed in claim 15,wherein the composition is stable for at least 15 weeks when stored at40° C.
 19. The composition as claimed in claim 15, wherein thecomposition has a viscosity of 50×10³ to 600×10³ cPs at 25° C.
 20. Thecomposition as claimed in claim 15, wherein the pH is between 4.0 and5.0 for the duration of storage.
 21. A composition for treating apatient consisting essentially of: a. 70-90 wt % honey; b. 2-10 wt %caprylyl/capryl glucoside; and c. 2-15 wt % myristyl myristate; whereinthe composition has been subjected to a sterilization effective dosageof radiation and is storage stable for a time period of at least 24hours at 40° C.